1. ¹Gastrointestinal Oncology Unit, Institut Gustave Roussy, Villejuif, France
2. ²Gastrointestinal Oncology Unit, Centre Eugene Marquis, Rennes, France
3. ³Biostatistics Unit, Institut Gustave Roussy, Villejuif, France
4. ⁴Gastrointestinal Unit, University Hospital, Reims, France
5. ⁵Hepato-Gastroenterology Unit, University Hospital, Bordeaux, France
6. ⁶Digestive Oncology Unit, la Timone Hospital and University of the Mediterranean, Marseille, France
7. ⁷Gastrointestinal Unit University Hospital, Dijon, France

Correspondence: Dr V Boige, Département de Médecine, Institut Gustave Roussy, 39, Rue Camille Desmoulins, 94800 Villejuif, France. E-mail: boige@igr.fr

Received 17 May 2007; Revised 3 July 2007; Accepted 8 August 2007; Published online 18 September 2007.

Abstract

Evaluation of new drug combinations is needed to improve patients' prognosis in advanced hepatocellular carcinoma (HCC). The purpose of this study was to evaluate the safety and efficacy of the capecitabine–oxaliplatine combination (XELOX) in HCC patients. First-line chemotherapy with XELOX regimen consisting of a 3-week cycle of intravenous oxaliplatin (130 mg m^-2) on Day 1, and oral capecitabine twice daily from Days 1–14 (1000 mg m^-2) was administered in patients with measurable, unresectable HCC. Fifty patients (male, 88%; median age, 68 years) received a total of 295 cycles (median, 6) of treatment. Disease control (three partial responses, 29 stable diseases) rate was 72% (95% CI 57–83%). Median overall and median progression-free (PFS) survival was 9.3 months and 4.1 months, respectively. Progression-free survival rates at 6 and 12 months were 38% (95% CI 26–52%) and 14% (95% CI 7–26%), respectively. Main grade 3–4 drug-related toxicities included diarrhoea (16%), elevation of aminotransferases and/or bilirubin (16%), thrombocytopenia (12%), and neurotoxicity (6%). Capecitabine plus oxaliplatin regimen showed modest anti-tumour activity with tolerable toxicities in patients with advanced HCC. However, the manageable toxicity profile and the encouraging disease control rate deserve further attention for this convenient, outpatient-based chemotherapy regimen.